Distal Protection Combined With PTCA in AMI Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2004-08-31

Brief Summary

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The primary objective is to evaluate if use of the AngioGuard™ XP improves myocardial reperfusion after PTCA as assessed by ST segment resolution at the end of PTCA.

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Detailed Description

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This is a prospective, randomized, multicenter trial. Patients will be randomized either to be treated by PTCA only or in combination with the An-gioGuard™ XP device. The patients will be followed for six-months post-procedure.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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1

PTCA

Group Type OTHER

PTCA

Intervention Type OTHER

PTCA

2

PTCA with angioguard

Group Type OTHER

Angioguard distal protection device

Intervention Type DEVICE

PTCA with the Angioguard distal protection device.

Interventions

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Angioguard distal protection device

PTCA with the Angioguard distal protection device.

Intervention Type DEVICE

PTCA

Intervention Type OTHER

Other Intervention Names

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Cordis AngioGuard™ XP

Eligibility Criteria

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Inclusion Criteria

* Acute myocardial infarction \< 12 hours with ST segment elevation \> 2 mm in at least 2 contiguous leads;
* Clinical indication of primary PTCA;
* De novo or restenotic lesions in native coronary vessel, single vessel treatment only;
* Target lesion stenosis is \> 80% (by visual estimation).

Exclusion Criteria

* Patient has unprotected left main coronary disease with \> 50% stenosis in case left coronary artery is treated;
* Patient has an ostial target lesion;
* Killip class \> 3.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No